State University of New York (SUNY) NEXT Clinical Site
State University of New York (SUNY) NEXT Clinical Site
批准号:
8731281
负责人:
STEVEN Richard LEVINE
金额:
$27.65万
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-09-30 至 2018-06-30
关键词:
AdultAffectAmericanChildhoodClinicalClinical InvestigatorClinical ResearchClinical TrialsClinical Trials DesignClinical Trials NetworkClinical trial protocol documentClinics and HospitalsCommunitiesCommunity HospitalsConduct Clinical TrialsData Coordinating CenterDevelopmentDiseaseEthicsFoundationsFundingGoalsGrantHealthHospitalsImProvIndustryInstitutesLeadershipLocal GovernmentMedicalMentorsMorbidity - disease rateNational Institute of Neurological Disorders and StrokeNeurologicNeurologyNeurosciencesNew YorkParticipantPatient RecruitmentsPatientsPerformancePhase III Clinical TrialsPopulationPopulation HeterogeneityProtocols documentationPublic HealthRecruitment ActivityResearchResearch InfrastructureResearch PersonnelResourcesRuralSiteSpecialistState GovernmentStructureTelemedicineTestingTrainingTranslational ResearchTranslationsUnderrepresented MinorityUnited States National Institutes of HealthUniversitiesWorkbaseclinical research siteeffective therapyexperiencegeographic populationimprovedinnovationmortalitynervous system disorderorganizational structurepatient advocacy grouppatient populationracial and ethnicresponsesuccess
中文摘要
描述(由申请人提供):本申请由纽约州立大学(SUNY)提交,旨在响应NINDS RFA,作为临床研究中心参与神经科学临床试验卓越网络(NEXT)。我们汇集了4个SUNY学术健康中心(AHC),他们的当地和不同的社区,以及他们与行业和医院和诊所网络的联系。这将确保一个强大的和可访问的基础设施,以促进快速发展和实施的协议,在神经系统疾病影响成人和儿科人群。通过将4个SUNY校区合并到一个应用程序中,我们创建了一个由具有极其多样化的种族和种族背景的患者组成的创新和非常庞大的网络,这将有助于对神经学临床试验的表现产生持续和强大的影响,从而更快地进入3期试验。在过去的几年里,成功的SUNY跨校园项目的势头急剧增加,主要领导层通过机构硬美元和赠款形成并支持SUNY REACH的形成。现在,SUNY REACH内对神经系统疾病有重要的支持和合作活动,SUNY NEXT提案将进一步加强基础设施并扩大我们的SUNY临床试验网络。我们已经建立了这个网络,并继续完善它,以提供全面的疾病特异性专业知识(成人和儿科神经科专家和亚专家),临床试验专业知识和经验,包括试验协调员,临床/转化研究基础设施,机构承诺,以及正在进行/扩大的基于社区的建议和研究。我们的网络可以协调一个庞大的,地理上多样化的专家研究人员的干部,以有效地实施研究,以应对特定疾病的机会。我们还有一组初级/新的临床试验者,包括代表性不足的少数民族研究者,我们将对他们进行神经病学临床试验的培训。鉴于我们在远程医疗方面的专业知识和连通性,我们将探索在与SUNY NEXT有关联的更偏远、更小的地点进行临床试验的可行性,以使美国农村地区在临床试验中获得更大的代表性。我们的成功将改变临床试验协作结构的范式,并最终改善公共卫生。
英文摘要
DESCRIPTION (provided by applicant): This application from the State University of New York (SUNY) responds to the NINDS RFA to participate as a Clinical Site in the Network for Excellence in Neuroscience Clinical Trials (NEXT). We have brought together the 4 SUNY Academic Health Centers (AHC), their local and diverse communities, and their liaisons with industry and hospital and clinic networks. This will insure a robust and accessible infrastructure to facilitate rapid development and implementation of protocols in neurological disorders affecting adult and pediatric populations. By combining 4 SUNY campuses into one application, we have created an innovative and very large network of patients with extremely diverse ethnic and racial backgrounds that will facilitate a sustained and powerful influence on neurological clinical trial performance leading to a faster pipeline to phase 3 trials. Momentum for successful SUNY cross-campus projects has increased dramatically over the past several years with key leadership forming and supporting the formation of SUNY REACH via institutional hard dollars and grants. There is now significant support and collaborative activities for neurological diseases within the SUNY REACH and this SUNY NEXT proposal will further enhance infrastructure and expand our SUNY Clinical Trials Network. We have built this network and continue to refine it to provide a comprehensive array of disease-specific expertise (adult and pediatric neurologic specialists and subspecialists), clinical trial expertise and experience including trial coordinators, clinical/translational research infrastructure, institutional commitment, and ongoing/expanding community-based advice and research. Our network can coordinate a large, geographically diverse cadre of specialist investigators to implement studies efficiently in response to disease-specific opportunities. We also have a group of junior/new clinical trialists, including under-represented minority investigators, who we will train in the performance of neurology clinical trials. We will explore, given our expertise and connectivity in telemedicine, the feasibility of performing clinical trials to more remote, smaller sites affiliate with the SUNY NEXT to gain greater representation of rural Americans into clinical trials. Our success will shift paradigms for collaborative structuring of clinical trials and ultimately improv public health.
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负责人:STEVEN Richard LEVINE
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海外基金